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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01241149 |
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Date of registration:
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15/11/2010 |
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Primary sponsor: |
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Public title:
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Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery
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Scientific title:
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Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery. |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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32 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01241149 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ellie Mentler, MD |
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Address:
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Telephone:
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757-953-2454 |
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Email:
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ellie.mentler@med.navy.mil |
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Affiliation:
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Name:
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Ellie Mentler, MD |
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Address:
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Telephone:
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757-953-2454 |
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Email:
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ellie.mentler@med.navy.mil |
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Affiliation:
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Name:
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Ellie Mentler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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United States Naval Medical Center, Portsmouth |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who are offered anti-reflux surgical treatment with elevated DeMeester
scores or with low (less than 14.7) DeMeester scores, but with positive impedance
scores (positive symptom index associated with reflux episodes).
Exclusion Criteria:
- • Previous major upper gastrointestinal surgery (includes esophagus, stomach, and
duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major
upper GI surgery
- Presence of paraesophageal hernia (type II - type IV)
- Presence of large hiatal hernia >5cm
- Presence of peptic strictures
- History of severe esophageal motility disorders such as:
- achalasia
- diffuse esophageal spasms
- scleroderma
- poorly-controlled diabetes mellitus
- autonomic or peripheral neuropathy
- myopathy
- Pregnancy (As a standard operating procedure, women of child-bearing age will
undergo a urine pregnancy test the morning of surgery because anti-reflux
surgery is considered an elective case, where pregnancy is a relative
contraindication.)
- BMI greater than 40
- Undergoes Collis gastroplasty during surgery
- Conversion to an open procedure
- Age less than 18 years old
Age minimum:
17 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-acid Reflux Disease
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Intervention(s)
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Procedure: anti-reflux surgery
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Primary Outcome(s)
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Effectiveness of anti-reflux surgery
[Time Frame: 1 year]
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Secondary ID(s)
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CIP# 10.0090
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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